Dear Listmembers:
Some good news for CML'ers who do not live close enough to NYC to
participate in the CML vaccine trial at Sloan-Kettering (www.mskcc.org)
.
Around or about the end of 2005, the Phase 2 trial will be expanded to MD
Anderson, UCLA, and Oregon, according to MSKCC sources. It appears that Dr.
Cortes at MDACC and Dr. Druker at OHSU will be involved with the trial.
Presumably, Dr. Sawyers will be involved at the UCLA trial, but I have not
confirmed this.
I survived the intial trial screening process at MSKCC on Wednesday,
having surrendered 14 vials of blood to establish the base-line data to measure
my immune response to the vaccine as well as some extra aspirate taken during
the bone marrow aspiration. I was told that Dr. David Scheinburg, inventor of
the vaccine, will personally receive a sample of the aspirate samples from trial
participants.
Present at the screening were my doctor, Dr. Gupta, head of the trial,
and Suzanne Chanel, the brilliant clinical trial nurse, who handles the
nuts-and-bolts of clinical trials at the hospital.
The official title of the trial, according to the patient informed
consent documents I signed is: "PIlot Trial of a Synthetic Tumor Specific
Breakpoint Peptide Vaccine in Patients with Chronic Myelogenous Leukemia and
Minimal Residual Disease."
You must show Philadelphia Chromosome positive on the RT-PCR to
qualify, so if I hit ZERO PCR, I won't qualify. (PCR in February was .00015% on
600 mg. of IM.)
If the PCR results shows positive, I return to MSKCC on Aug. 3 for the
first inoculation.
If the PCR result shows negative, I'll jump for joy. Talk about a
win-win situation!
I'll provide addtional information about the trial in future posts.
Meanwhile, if you are interested in further information on the vaccine there is
an article on Jennifer's excellent website detailing the results of an earlier
MSKCC trial:
Just go this link and download the article :
"A multivalent bcr-abl fusion peptide vaccination trial in patients with
chronic myeloid leukemia
You may also contact Dr. Gupta, the trial head, at: (212) 639-2327
email: guptas@....
Best regards,
Carl Davies
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